Study of Efficacy, Safety and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis

• Status: Recruiting
• Trial end date: 2023-03-13
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this proof of concept study is to determine whether CMK389 displays the safety and efficacy profile to support further development in chronic pulmonary sarcoidosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Subjects must have a body mass index (BMI) at screening within the range of 18 - 43 kg/m2. BMI = Body weight (kg) / [Height (m)]2

• Biopsy proven pulmonary sarcoidosis diagnosed > 1 year prior to screening

• Scadding stage II, III or IV as determined by the most recent chest x-ray obtained within 12 months prior to screening or at screening (confirmed by the Investigator)

• HRCT extent of fibrosis <15% (confirmed by the central imaging reader) at screening

• Treatment with 5-15 mg/day prednisone (or prednisone oral equivalents) for ≥ 6 months prior to screening.

• Co-medication with methotrexate or azathioprine for ≥ 6 months prior to screening (Note: hydroxychloroquine is allowed as background therapy but not required)

• Able to perform reliable, reproducible pulmonary function test maneuvers per American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines

Exclusion Criteria:

• Diagnosis of significant pulmonary hypertension (WHO group 5) requiring pharmacological treatment

• A known diagnosis of cardiac sarcoidosis

• A known diagnosis of neurosarcoidosis

• Forced vital capacity (FVC) <50% of predicted at screening (central read)

• Modified British Medical Research Council (mMRC) dyspnea scale ≥ 3 at screening

• Concomitant treatment with leflunomide, cyclophosphamide, mycophenolate, infliximab, etanercept, adalimumab, golimumab, ustekinumab, roflumilast, pentoxifylline, and abatacept within 12 weeks of screening

• Prior treatment with rituximab, canakinumab, anakinra, and tocilizumab

• Current smokers, defined as inhaled use of tobacco products

• Any conditions or significant medical problems which in the opinion of the investigator and in consultation with the sponsor, immunocompromises the patient and/or places the patient at unacceptable risk for immunomodulatory therapy

• Contraindication to FDG-PET scan investigations such as severe claustrophobia or uncontrolled diabetes

• History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study

• A diagnosis of Lofgren's syndrome

• A history of pancreatitis

• Other protocol-defined inclusion/exclusion criteria may apply